<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20150929024266N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-24</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the clinical response rate of patients with lower rectal cancer after combined treatment with intensity-modulated chemoradiotherapy and pre-surgical chemotherapy</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the rate of complete clinical response following total neoadjuvant therapy by using chemoradiotherapy by Intensity modulated radiation therapy with simultaneous integrated boost (IMRT-SIB) in patients with lower rectal cancer; a Phase II randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74567</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>rectal cancer.</hc_freetext>
      <i_freetext>The target population is people over 18 years of age with non-metastatic rectal cancer that are less than 5 cm from the anus and have good clinical conditions.Patients undergoing radiotherapy using 25-66/57 GTV, SIB and 25/45 CTV will receive five days a week (Saturday to Wednesday) and will be treated with chemotherapy regimen with Xeloda 825 2m/mg twice a day orally between The first to fourteenth days will be arranged. SIB-PTV will be gross tumor on MRI plus 1 cm of geometric margin. After radiotherapy, T3/4 or N+ patients undergo chemotherapy with one of XELOX or FOLFOX regimens. Examining the results of patients 12-16 weeks after the end of treatment will be done by MRI and colonoscopy.The MRI report must be reviewed by two people separately or reported by an experienced person. If there is a good response to the treatment and the tumor has decreased in size significantly, the chemotherapy is continued until 16 weeks are completed, and then a re-evaluation similar to the first evaluation is done. Patients with complete clinical response enter the Wait and W protocol if the patient agrees and other conditions are met (regular follow-up visits and surgeon's approval).Complete response means the absence of residual activity in MRI and the absence of tumor, ulcer or polyp in colonoscopy. If there is no suitable response, the patient will be referred for surgery and the rest of the chemotherapy will be done after the operation..</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Ghalehtaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Keshavarz Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6119 2520</telephone>
        <email>r-ghaletaki@student.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Ghalehtaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Keshavarz Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6119 2520</telephone>
        <email>r-ghaletaki@student.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Non-metastatic rectal cancer (&gt;T2N0) that is less than 5 cm from the anal wedge</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Inability to do MRI (whether mechanical or claustrophobia)
Lack of proper MRI for disease staging
Multiple comorbidities
Inadequate blood, kidney, or liver indices for the possibility of receiving chemotherapy
History of previous malignancies in the pelvis or other areas of the intestine, history of previous surgeries or radiotherapy in the pelvic area
MSI-H patients who are candidates for immunotherapy
History of IBD or FAP and other colon polyposis syndromes
Active malignancies in other areas of the body.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of rectum</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The target population is people over 18 years of age with non-metastatic rectal cancer that are less than 5 cm from the anus and have good clinical conditions.Patients undergoing radiotherapy using 25-66/57 GTV, SIB and 25/45 CTV will receive five days a week (Saturday to Wednesday) and will be treated with chemotherapy regimen with Xeloda 825 2m/mg twice a day orally between The first to fourteenth days will be arranged. SIB-PTV will be gross tumor on MRI plus 1 cm of geometric margin. After radiotherapy, T3/4 or N+ patients undergo chemotherapy with one of XELOX or FOLFOX regimens. Examining the results of patients 12-16 weeks after the end of treatment will be done by MRI and colonoscopy.The MRI report must be reviewed by two people separately or reported by an experienced person. If there is a good response to the treatment and the tumor has decreased in size significantly, the chemotherapy is continued until 16 weeks are completed, and then a re-evaluation similar to the first evaluation is done. Patients with complete clinical response enter the Wait and W protocol if the patient agrees and other conditions are met (regular follow-up visits and surgeon's approval).Complete response means the absence of residual activity in MRI and the absence of tumor, ulcer or polyp in colonoscopy. If there is no suitable response, the patient will be referred for surgery and the rest of the chemotherapy will be done after the operation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The rate of clinical response in MRI and colonoscopy. Timepoint: 12 to 16 weeks after completion of treatment. Method of measurement: Reduction in size or complete disappearance of mass in MRI and colonoscopy.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Deputy of Research, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-01</approval_date>
        <contact_name>Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences</contact_name>
        <contact_address>Poursina Street, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
